Assessment of the tolerance and effectiveness of a food supplement Sérélys® (Femal®) for menopausal women

Hot flushes and night sweats are one of the most common signs of a lack of oestrogen caused by the menopause. The length of these symptoms varies enormously. If they are extremely frequent during the first few years after the menopause (figure 1) they will continue for 20 % of women from 70-74 years of age (figure 2). HRT (Hormone Replacement Treatment), from the time that it brings a sufficient dosage of oestrogen, makes these heat-related symptoms disappear within 10 to 15 days for the large majority of women concerned. The WHI study published 6 years ago, because it compared the increase in breast cancer and cardiovascular risks for women using these treatments, nowadays no longer makes people take any notice. The consequences of the debate: almost half of women who would normally use HRT either preferred not to start it or to stop it of their own accord or on the advice of their doctor. The consequences of stopping HRT are amongst other things a substantial increase in the number of women complaining of hot flushes and night sweats. The alternatives to HRT are represented by the beta-alanine (Abufène®), considered by many people as not very effective, the veralipride (Agréal®), withdrawn from the market, and the soya isoflavones, which were severely discredited in the joint report by the AFFSAPS and the AFFSA drawn up in 2005 by patients and doctors. In this context we have studied the effectiveness/tolerance of a new natural product amongst menopausal women: Sérélys® (Femal®) whose active agent is composed of pollen cytoplasmic extracts making it of interest. This product has already been used in Europe since 1999. It has been the subject of several studies, two of which were a double blind against placebo, which showed it was of interest in the treatment of hot flushes and night sweats associated with the menopause. Here we report on a trial in which 102 French doctors participated (91 % gynaecologists) having included 417 women.